FDA.reportPublic FDA data

Orthex Drill Solid

Primary DI
00841731113290
Brand
Orthex Drill Solid
Company
VILEX IN TENNESSEE, INC.
Model
Z402-250-45
Device description
Orthex, Drill 4.5x250mm Solid
Published
2017-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTWBit, Drill
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151881000X-Fix Line AdditionsVilex IN Tennessee, Inc.2016-03-24KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731113290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731113290008417311132908417311132900841731113290

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-use, non-sterileAn assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
152008371
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731120274Vilex GuidewireK100-09DK100-09D2018-08-06
00841731120281Vilex GuidewireK100-09GK100-09G2018-08-06
00841731120298Vilex GuidewireK100-09SK100-09S2018-08-06
00841731120304Vilex GuidewireK100-11DK100-11D2018-08-06
00841731120311Vilex GuidewireK100-11PTK100-11PT2018-08-06
00841731120328Vilex GuidewireK100-11SK100-11S2018-08-06
00841731120335Vilex GuidewireK100-12SK100-12S2018-08-06
00841731120342Vilex GuidewireK100-14SK100-14S2018-08-06
00841731120359Vilex GuidewireK100-16DK100-16D2018-08-06
00841731120366Vilex GuidewireK100-16SK100-16S2018-08-06
00841731120373Vilex GuidewireK100-20SK100-20S2018-08-06
00841731120441Vilex Plate GuidewireK11-60TK11-60T2018-08-08
00841731120465Vilex GuidewireK150-09DK150-09D2018-08-08
00841731120472Vilex GuidewireK150-11DK150-11D2018-08-08
00841731120489Vilex GuidewireK150-11PTK150-11PT2018-08-08
00841731120496Vilex GuidewireK150-11SK150-11S2018-08-08
00841731120502Vilex GuidewireK150-12DK150-12D2018-08-08
00841731120519Vilex GuidewireK150-12SK150-12S2018-08-08
00841731120526Vilex GuidewireK150-14DK150-14D2018-08-08
00841731120533Vilex GuidewireK150-14SK150-14S2018-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888867574557Arthrex®ARTHREX, INC.HTW2026-09-18
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
00884450681381Preston™Merit Medical Systems, Inc.HTW2026-08-21
00884450681398Preston™Merit Medical Systems, Inc.HTW2026-08-21
00840606191791Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191807Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
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00840606191821Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191852Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195768Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195775Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
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